(35 days)
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.
The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
The provided text is a 510(k) summary for the Syneron Medical Ltd. AURORA DS device. It outlines the company, device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence for a modification (an increase in RF energy output) to an already cleared device. It explains that the modification does not affect intended use or fundamental scientific technology and raises no new safety or effectiveness issues.
Therefore, I cannot provide the requested table and study details as they are not present in the given input.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.